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An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Primary Purpose

Non-Hodgkins Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Glofitamab
Atezolizumab
Obinutuzumab
Tocilizumab
Polatuzumab Vedotin
89Zr-Df-IAB22M2C
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkins Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria

  • Histologically-confirmed hematologic malignancy that is expected to express CD20 (Relapsed after or refractory to respond to at least one prior treatment regimen; no available treatment options that are expected to prolong survival or patients refusing chemotherapy or autologous stem cell transplant (SCT). Note: The expansion part is restricted to relapsed/refractory follicular lymphoma (r/r FL) and relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL))
  • At least one measurable target lesion
  • Fresh pre-treatment biopsy, but if this cannot be taken, a previous archived biopsy from metastatic lesion can be taken as replacement if it is not older than 6 months and not confounded by major events (progression, treatment)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Adequate organ function (liver, hematological, renal)
  • Negative test results for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)

Inclusion Criteria Specific to Imaging Substudy

  • At least two measurable target lesions
  • Able to provide two fresh tumor biopsies (baseline and on-treatment)

Main Exclusion Criteria

  • Participants with Chronic Lymphocytic Leukemia (CLL), acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma, Richter's transformation, CD20-positive ALL, Burkitt lymphoma, or lymphoplasmacytic lymphoma
  • Current > Grade 1 peripheral neuropathy (only for participants being treated in the polatuzumab vedotin arm)
  • Patients with known active infection, or reactivation of a latent infection within 4 weeks prior to Obinutuzumab (Gpt) infusion
  • Patient with history of confirmed progressive multifocal leukoencephalopathy (PML)
  • History of leptomeningeal disease
  • Current or past history of central nervous system (CNS) lymphoma
  • Current or past history of CNS disease
  • Major surgery or significant traumatic injury </=28 days prior to Gpt infusion
  • Significant cardiovascular disease or significant pulmonary disease
  • Active or history of autoimmune disease or immune deficiency (with exceptions, e.g. hypothyroidism and Diabetes mellitus Type 1)
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Treatment with any other standard anti-cancer radiotherapy / chemotherapy including investigational therapy within 4 weeks prior to Gpt infusion
  • Prior solid organ transplantation
  • Prior allogenic stem cell transplant (SCT)
  • Autologous SCT within 100 days prior to Gpt infusion
  • Documented refractoriness to an obinutuzumab-monotherapy regimen
  • Prior treatment with anti-cancer/lymphoma therapies and systemic immunotherapeutic/immunostimulating agents within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to Gpt infusion
  • Any history of immune related >/= Grade 3 adverse events (AE) with the exception of endocrinopathy managed with replacement therapy
  • Ongoing corticosteroid use >25 milligrams/day of prednisone or equivalent within 4 weeks prior to and during study treatment
  • Treatment with systemic immunosuppressive medication
  • Administration of a live, attenuated vaccine within 4 weeks prior to Gpt infusion or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after last dose of study treatment

Exclusion Criteria Specific to Imaging Substudy

  • Circulating lymphoma cells, defined by out of range (high) absolute lymphocyte count and/or the presence of abnormal/malignant cells in the peripheral blood differential signifying circulating lymphoma cell
  • Participants who have had splenectomy or functional asplenia that could compromise protocol objectives

Sites / Locations

  • Novant Health Cancer Institute
  • Ohio State University; Clinical Investigations Office
  • UZ Gent
  • Aarhus Universitetshospital Skejby; BlodsygdommeRecruiting
  • Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KATRecruiting
  • Odense Universitetshospital; Hæmatologisk AfdelingRecruiting
  • Hadassah Ein Karem Hospital; HaematologyRecruiting
  • Rabin Medical Center-Beilinson Campus;Hematology-OncologyRecruiting
  • Chaim Sheba Medical Center; Department of HematologyRecruiting
  • Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
  • Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli"
  • ASST PAPA GIOVANNI XXIII; EmatologiaRecruiting
  • Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia
  • Hospital Universitari Vall d'Hebron; Servicio de HematologiaRecruiting
  • Hospital Duran i Reynals; Servicio de Hematologia
  • START Madrid-FJD, Hospital Fundacion Jimenez DiazRecruiting
  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio HematologiaRecruiting
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • The HOPE Clinical Trials Unit
  • University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility
  • The Newcastle upon Tyne Hospitals NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Atezolizumab

Polatuzumab Vedotin

Imaging Sub-study

Arm Description

Participants will receive Glofitamab in combination with Atezolizumab up to the maximum tolerated dose (MTD).

Participants will receive Glofitamab in combination with polatuzumab vedotin up to the MTD.

Participants will undergo positive-emission tomography/computed tomography (PET/CT) at screening, followed by an "Imaging Cycle," to replace Cycle 1 of the main study. Eligible participants will have the option roll-over to the atezolizumab arm of the main study from Cycle 2 onwards.

Outcomes

Primary Outcome Measures

Dose Limiting Toxicities (DLTs)
Change in Maximum Standardized Update Value (SUVmax) Based on 89Zr-PET/CT Scans
Change in Peak SUV (SUVpeak) Based on 89Zr-PET/CT Scans
Change in Mean SUV (SUVmean) Based on 89Zr-PET/CT Scans
Change in CD8 Tumor Volume Based on 89Zr-PET/CT

Secondary Outcome Measures

Percentage of Participants with Adverse Events (AEs)
Anti-Drug Antibody (ADA) Formation
Complete Response (CR) Rate, as Assessed by Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography (FDG-PET/CT) Scan
Objective Response Rate (ORR)
Disease Control Rate (DCR)
Duration of Response (DOR)
Duration of Complete Response
Time to First Complete Response (TFCR)
Time to First Overall Response (TFOR)
Progression-Free Survival (PFS)
Overall Survival (OS)
Elimination Half-Life (T1/2) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
Area Under the Concentration-Time Curve (AUC) for Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
Time to Maximum Observed Serum Concentration (Tmax) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
Maximum Observed Serum Concentration (Cmax) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
Minimum Serum Concentration (Cmin) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
Clearance (CL) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
Volume of Distribution at Steady-State (Vss) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
CD8-Positive T Cell Proliferation
CD20-Positive B-Cell Reduction
SUVmax of 89Zr-Df-IAB22M2C
SUVpeak of 89Zr-Df-IAB22M2C
SUVmean of 89Zr-Df-IAB22M2C
Tumor Volume Based on 89Zr-Df-IAB22M2C PET-uptake
Quantitation of CD8+ Cells on Biopsy Samples

Full Information

First Posted
May 4, 2018
Last Updated
October 3, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03533283
Brief Title
An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Official Title
An Open-Label, Multi-Center, Phase IB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin (Plus a Single Pre-Treatment Dose of Obinutuzumab) in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2018 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is an open-label, single arm, multicenter, dose finding, Phase Ib study in order to assess the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for this combination treatment and to evaluate the general safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and preliminary anti-tumor activity of this combination treatment in adult patients. This study includes an additional open-label imaging feasibility sub-study using a tracer in adult participants with relpased/refractory B-cell non-Hodgkin's lymphoma to image CD8+T-cells at baseline and after treatment with glofitamab, including pre-treatment with obinutuzumab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkins Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab
Arm Type
Experimental
Arm Description
Participants will receive Glofitamab in combination with Atezolizumab up to the maximum tolerated dose (MTD).
Arm Title
Polatuzumab Vedotin
Arm Type
Experimental
Arm Description
Participants will receive Glofitamab in combination with polatuzumab vedotin up to the MTD.
Arm Title
Imaging Sub-study
Arm Type
Experimental
Arm Description
Participants will undergo positive-emission tomography/computed tomography (PET/CT) at screening, followed by an "Imaging Cycle," to replace Cycle 1 of the main study. Eligible participants will have the option roll-over to the atezolizumab arm of the main study from Cycle 2 onwards.
Intervention Type
Drug
Intervention Name(s)
Glofitamab
Other Intervention Name(s)
RO7082859
Intervention Description
Glofitamab will be administered through IV infusion every 3 weeks (Q3W) beginning Cycle 1, Day 1, for up to 17 cycles (Cycle = 21 days). Step-up dosing, in which an initial lower dose will be followed by a higher dose 1 week later, will be considered for the initial treatment phase and for Cycle 9 of the re-treatment phase.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
Atezolizumab will be administered in combination with Glofitamab through IV infusion Q3W from Cycle 2, Day 1, for up to 16 cycles (Cycle = 21 days).
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Intervention Description
Obinutuzumab will be administered once, through IV infusion, at a fixed dose 7 days before the first dose of Glofitamab.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
Actemra
Intervention Description
Tocilizumab will be administered as necessary to treat cytokine release syndrome (CRS).
Intervention Type
Drug
Intervention Name(s)
Polatuzumab Vedotin
Intervention Description
Polatuzumab vedotin will be administered in combination with Glofitamab (on different days) Q3W from Cycle 1, Day 2, for up to 12 cycles (Cycle = 21 days).
Intervention Type
Drug
Intervention Name(s)
89Zr-Df-IAB22M2C
Intervention Description
Participants will receive 89Zr-Df-IAB22M2C (Cycle 1 only) prior to obinutuzumab pre-treatment and again on Day 10 after dosing with glofitamab, followed by PET/CT.
Primary Outcome Measure Information:
Title
Dose Limiting Toxicities (DLTs)
Time Frame
Atezolizumab Arm: During DLT period of 21 days (or up to 42 days in the case of cycle delay), starting on Day 1, Cycle 2; Polatuzumab Vedotin Arm: During 5-week DLT period starting Cycle 1, Day 8
Title
Change in Maximum Standardized Update Value (SUVmax) Based on 89Zr-PET/CT Scans
Time Frame
From baseline to Day 13
Title
Change in Peak SUV (SUVpeak) Based on 89Zr-PET/CT Scans
Time Frame
From baseline to Day 13
Title
Change in Mean SUV (SUVmean) Based on 89Zr-PET/CT Scans
Time Frame
From baseline to Day 13
Title
Change in CD8 Tumor Volume Based on 89Zr-PET/CT
Time Frame
From baseline to Day 13
Secondary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)
Title
Anti-Drug Antibody (ADA) Formation
Time Frame
Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)
Title
Complete Response (CR) Rate, as Assessed by Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography (FDG-PET/CT) Scan
Time Frame
Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)
Title
Objective Response Rate (ORR)
Time Frame
Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)
Title
Disease Control Rate (DCR)
Time Frame
Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)
Title
Duration of Response (DOR)
Time Frame
Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)
Title
Duration of Complete Response
Time Frame
Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)
Title
Time to First Complete Response (TFCR)
Time Frame
Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)
Title
Time to First Overall Response (TFOR)
Time Frame
Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)
Title
Progression-Free Survival (PFS)
Time Frame
Baseline until end of treatment (13 to 14 months), then every 3 months until end of study visit (to occur within 4 weeks of disease progression)
Title
Overall Survival (OS)
Time Frame
Baseline through end of survival follow-up phase (survival follow-up is every 3 months until death, lost to follow-up, withdrawal of consent, or study termination)
Title
Elimination Half-Life (T1/2) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
Time Frame
At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)
Title
Area Under the Concentration-Time Curve (AUC) for Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
Time Frame
At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)
Title
Time to Maximum Observed Serum Concentration (Tmax) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
Time Frame
At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)
Title
Maximum Observed Serum Concentration (Cmax) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
Time Frame
At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)
Title
Minimum Serum Concentration (Cmin) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
Time Frame
At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)
Title
Clearance (CL) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
Time Frame
At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)
Title
Volume of Distribution at Steady-State (Vss) of Glofitamab Administered in Combination with Atezolizumab or Polatuzumab Vedotin
Time Frame
At pre-defined intervals through the end of study (EoS) visit (to occur within 4 weeks of disease progression)
Title
CD8-Positive T Cell Proliferation
Time Frame
At pre-defined intervals during the study treatment period (up to 17 cycles; Cycle = 21 days)
Title
CD20-Positive B-Cell Reduction
Time Frame
At pre-defined intervals during the study treatment period (up to 17 cycles; Cycle = 21 days)
Title
SUVmax of 89Zr-Df-IAB22M2C
Time Frame
From baseline to Day 13
Title
SUVpeak of 89Zr-Df-IAB22M2C
Time Frame
From baseline to Day 13
Title
SUVmean of 89Zr-Df-IAB22M2C
Time Frame
From baseline to Day 13
Title
Tumor Volume Based on 89Zr-Df-IAB22M2C PET-uptake
Time Frame
From baseline to Day 13
Title
Quantitation of CD8+ Cells on Biopsy Samples
Time Frame
From baseline to Day 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria Histologically-confirmed hematologic malignancy that is expected to express CD20 (Relapsed after or refractory to respond to at least one prior treatment regimen; no available treatment options that are expected to prolong survival or patients refusing chemotherapy or autologous stem cell transplant (SCT). Note: The expansion part is restricted to relapsed/refractory follicular lymphoma (r/r FL) and relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL)) At least one measurable target lesion Fresh pre-treatment biopsy, but if this cannot be taken, a previous archived biopsy from metastatic lesion can be taken as replacement if it is not older than 6 months and not confounded by major events (progression, treatment) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Adequate organ function (liver, hematological, renal) Negative test results for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) Inclusion Criteria Specific to Imaging Substudy At least two measurable target lesions Able to provide two fresh tumor biopsies (baseline and on-treatment) Main Exclusion Criteria Participants with Chronic Lymphocytic Leukemia (CLL), acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma, Richter's transformation, CD20-positive ALL, Burkitt lymphoma, or lymphoplasmacytic lymphoma Current > Grade 1 peripheral neuropathy (only for participants being treated in the polatuzumab vedotin arm) Patients with known active infection, or reactivation of a latent infection within 4 weeks prior to Obinutuzumab (Gpt) infusion Patient with history of confirmed progressive multifocal leukoencephalopathy (PML) History of leptomeningeal disease Current or past history of central nervous system (CNS) lymphoma Current or past history of CNS disease Major surgery or significant traumatic injury </=28 days prior to Gpt infusion Significant cardiovascular disease or significant pulmonary disease Active or history of autoimmune disease or immune deficiency (with exceptions, e.g. hypothyroidism and Diabetes mellitus Type 1) History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan Treatment with any other standard anti-cancer radiotherapy / chemotherapy including investigational therapy within 4 weeks prior to Gpt infusion Prior solid organ transplantation Prior allogenic stem cell transplant (SCT) Autologous SCT within 100 days prior to Gpt infusion Documented refractoriness to an obinutuzumab-monotherapy regimen Prior treatment with anti-cancer/lymphoma therapies and systemic immunotherapeutic/immunostimulating agents within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to Gpt infusion Any history of immune related >/= Grade 3 adverse events (AE) with the exception of endocrinopathy managed with replacement therapy Ongoing corticosteroid use >25 milligrams/day of prednisone or equivalent within 4 weeks prior to and during study treatment Treatment with systemic immunosuppressive medication Administration of a live, attenuated vaccine within 4 weeks prior to Gpt infusion or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after last dose of study treatment Exclusion Criteria Specific to Imaging Substudy Circulating lymphoma cells, defined by out of range (high) absolute lymphocyte count and/or the presence of abnormal/malignant cells in the peripheral blood differential signifying circulating lymphoma cell Participants who have had splenectomy or functional asplenia that could compromise protocol objectives
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: NP39488 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Novant Health Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Ohio State University; Clinical Investigations Office
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Withdrawn
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Aarhus Universitetshospital Skejby; Blodsygdomme
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Odense Universitetshospital; Hæmatologisk Afdeling
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Hadassah Ein Karem Hospital; Haematology
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center-Beilinson Campus;Hematology-Oncology
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Chaim Sheba Medical Center; Department of Hematology
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli"
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
ASST PAPA GIOVANNI XXIII; Ematologia
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Duran i Reynals; Servicio de Hematologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
The HOPE Clinical Trials Unit
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility
City
London
ZIP/Postal Code
W1T 7HA
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

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